Inven2 manages the contract process on behalf of the hospital/investigator. The contract process runs is parallel to the budget process, and includes quality control of the contract content and negotiations with sponsor regarding payments and other terms.
Inven2 has an IPR unit that provides legal advises in the contract negotiations. Inven2 also has a set of standard contract templates that can be used at sponsor's discretion.
Inven2 coordinate the signing of the contract at the hospital and keep one original in a fire proof looker in addition to a scanned version.
The hospital accepts the use of scanned signatures on study agreements. We encourage sponsors to accept the same, as this greatly reduces the time it takes to collect the necessary signatures.
Hospital Pharmacies Enterprise (Sykehusapotekene HF), South-Eastern Norway and Inven2 have entered into an agreement for the handling of contracts in clinical studies. For clinical studies notified to Inven2 from 17th August 2015, Inven2 will be responsible for negotiating the legal text in contracts between Hospital Pharmacies and Sponsor, on behalf of the Hospital Pharmacies. The Hospital Pharmacy will be responsible for specifying tasks and negotiate prices with Sponsor for each single clinical study (one Hospital Pharmacy will be responsible in multi-site studies). For further info (in Norwegian) see https://sykehusapotekene.no/fag-og-forskning/forskning/kliniske-studier.
Inven2 agreement templates for clinical studies
Inven2 has developed agreement templates for both clinical studies of pharmaceutical compounds and medical devices. The templates incorporate current standards and guidelines from the hospitals as well as relevant Norwegian and international legislation and established practice. The templates can be used by companies that do not have an agreement template of their own, to get a better understanding of the legal framework the hospital can accept, or they can serve as inspiration for the development of a company’s own templates.
The «Guidelines for Intellectual Property Rights and Publication» at Oslo University Hospital can be found here.
The Clinical Trial Agreement shall be signed by Head of the Hospital Department, VP Clinical Inven2 and sponsor. Inven2 and the Hospital will share the same original of the signed contract, as the original will be stored in a fire proof safe at Inven2 while the hospital receives a scanned copy of the original for electronic filing.
Obligations of the parties
The liability allocation between the parties is:
- The Sponsor liability is according to Good Clinical Practice (GCP).
- The hospital/investigator is liable for the investigator obligations according to GCP. This includes the scientific liability, patient recruitment and the medical follow up of patients.
- Inven2 is responsible for the contract process and financial follow up (Payee).